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About Company

Synergen Bio Private Limited was founded by a group of driven professionals with the goal of creating a premier clinical research organization renowned for its quality, knowledge, and expertise. It is a new age CRO approved by DCGI (CDSCO) with all the infrastructure needed to serve the pharmaceutical and biotech industries.

Position Name :

Sr. Manager

Organization :

Synergen Bio


B. Pharm, M.Pharm, MSc


10+ years




Shivajinagar, Wakadewadi, Pune

Position: Sr. Manager
Department: Project Management and Biopharmaceutics


  • B. Pharm, M.Pharm, MSc


  • 10+ years

Vacancies: 01
Preferred: Immediate joiner
Location: Shivajinagar, Wakadewadi, Pune

Tasks and Responsibilities:

  • Team Leadership: Lead the Bio-PK team to plan and execute BA/BE studies for various regulatory markets.
  • PK Study Design: Manage the design of PK studies for demonstrating bioequivalence (BE) for solid, liquid, topical, and specialized dosage forms, including parental.
  • Research and Writing: Conduct extensive literature searches, medical narrative writing, and summary report writing.
  • Cross-functional Coordination: Coordinate with all cross-functional teams to support and develop clinical research projects.
  • Pilot Study Review: Review and evaluate pilot bio-study clearance reports and results before initiating pivotal bio studies to ensure success.
  • Protocol Development: Develop, review, and recommend scientifically supported PK study BE protocols for ANDAs.
  • Study Report Review: Review draft and final BE study reports to ensure compliance with scientific and regulatory requirements.
  • Medical Writing Management: Oversee and manage all medical writing activities.
  • Client Support: Provide support to clients regarding CRO services.
  • Risk Management: Proactively identify risks in ongoing studies and resolve issues in consultation with respective departments and sponsors.
  • Document Preparation: Prepare service agreements and other confidential documents.
  • Logistic Support: Ensure logistical support from sponsors.
  • Regulatory Submission: Submit DCGI NOC documents to the office of DCGI for BA/BE study approval on time.
  • Project Slotting: Coordinate with clinical operations and screening teams for project slotting.

Interested candidates can share their CVs at: careers@synergenbio.com